Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

PHASE2CompletedINTERVENTIONAL
Enrollment

789

Participants

Timeline

Start Date

June 15, 2018

Primary Completion Date

October 15, 2019

Study Completion Date

November 4, 2019

Conditions
Chronic Heart Failure With Preserved Ejection Fraction
Interventions
DRUG

Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets

Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.

DRUG

Placebo

Placebo and sham up-titration at weeks 2, 4, and 6

Trial Locations (177)

0

Caja de Compensación Familiar CAFAM, Bogotá

112

Cheng Hsin General Hospital, Taipei

220

Far Eastern Memorial Hospital, New Taipei City

1027

Budai Irgalmasrendi Korhaz, Budapest

1060

Zentrum f. klinische Studien Dr. Hanusch GmbH, Vienna

1090

Universitätsklinikum AKH Wien, Vienna

1134

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz, Budapest

1202

Second Medical Center Sofia EOOD, Sofia

1210

Klinik Floridsdorf - Krankenhaus Nord, Vienna

1233

NMTH Tzar Boris III, Sofia

V MHAT, Sofia

2300

Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik, Pernik

2400

H. Hartziekenhuis Mol, Mol

2650

UZ Antwerpen, Edegem

3100

Universitätsklinikum St. Pölten, Sankt Pölten

3200

Pharma4Trial Kft., Gyöngyös

3400

Inst. de Cardiología de Corrientes Juana Francisca Cabral, Corrientes

4000

Multiprofile Hospital for Active Treatment Medline Clinic, Plovdiv

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4052

Nash Ranjith Research Centre, Merebank

4067

Durban Medical Centre, Durban

4400

Multiprofile Hospital for Active Treatment Pazardzhik, Pazardzhik

Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft., Nyíregyháza

4700

MHAT Dr. Bratan Shukerov AD, Smolyan

5280

Krankenhaus St. Josef Braunau, Braunau am Inn

5800

Specialized Hospital for Actrive Treatm of Card - Pleven, Pleven

7130

Vergelegen Medi-Clinic, Somerset West

7500

TREAD Research cc, Cape Town

7531

Tiervlei Trial Centre, Cape Town

8000

AZ St-Jan Brugge Oostende AV, Bruges

8036

Medizinische Universität Graz, Graz

8800

AZ Delta, Roeselare

Kanizsai Dorottya Hospital, Nagykanizsa

9010

MHAT Sveta Marina EAD, Varna

9300

Algemeen Stedelijk Ziekenhuis Campus Aalst, Aalst

10016

National Taiwan University Hospital, Taipei

11217

Taipei Veterans General Hospital, Taipei

11527

G. GENNIMATAS General State Hospital of Athens, Athens

14561

KAT General Hospital of Athens, Kifisia / Athens

15200

Hospital Raja Perempuan Zainab II, Kelantan

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

17011

Capital Area Research, LLC, Camp Hill

20089

IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A., Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21401

Anne Arundel Health System, Annapolis

22041

Cardiologicum Hamburg - Praxen Wandsbek, Hamburg

23462

Corporation Lane Research Center, Virginia Beach

24127

ASST Papa Giovanni XXIII, Bergamo

25123

ASST Spedali Civili di Brescia, Brescia

27100

IRCCS Fondazione Policlinico San Matteo, Pavia

27157

Wake Forest Baptist Health, Winston-Salem

28023

Hospital Sanitas La Zarzuela, Aravaca

28222

Hospital Universitario Clinica Puerta de Hierro, Majadahonda

29010

Hospital Virgen de la Victoria, Málaga

29720

Carolina Heart Specialists, Lancaster

32086

East Coast Institute for Research, LLC, Saint Augustine

32117

Cardiology Associates Research Company, Daytona Beach

32545

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW), Bad Oeynhausen

33130

LifeSpring Research Foundation, LLC, Miami

33449

Cardiology Partners, Wellington

33472

Cardiology Associates Of South Florida PA, Boynton Beach

34102

Southwest Florida Research, Naples

34209

Cardiovascular and Vein Center of Florida, Bradenton

36312

Hospital Álvaro Cunqueiro, Babio - Beade

38138

Stern Cardiovascular Center, Germantown

39466

Riser Medical Associates, Picayune

40138

A.O.U. di Bologna Policlinico S.Orsola Malpighi, Bologna

41014

Complejo Hospitalario Ntra. Sra. de Valme, Seville

41063

Kliniken Maria Hilf GmbH, Mönchengladbach

41100

University General Hospital of Larissa, Larissa

42303

Research Integrity, LLC, Owensboro

44124

A.O.U. di Ferrara, Ferrara

47374

Reid Health, Richmond

48202

Henry Ford Health System, Detroit

50400

Institute Jantung Negara, Kuala Lumpur

54636

"AHEPA University General Hospital of Thessaloniki", Thessaloniki

54642

Hippokration General Hospital of Thessaloniki, Thessaloniki

55131

St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz, Mainz

59901

Glacier View Research Institute, Kalispell

60048

Advocate Condell Medical Center, Libertyville

60506

Fox Valley Clinical Research Center, LLC, Aurora

63136

St. Louis Heart & Vascular, PC, St Louis

68506

Bryan Heart, Lincoln

70403

Heart Clinic of Hammond, Hammond

80923

Penrose-St. Francis Health Services, Colorado Springs

90211

WestSide Medical, Beverly Hills

91307

Interventional Cardiology Medical Group, West Hills

94300

Sarawak Heart Centre, Sarawak

95608

Capitol Interventional Cardiology, Carmichael

97078

Klinikum der Universität Würzburg, Würzburg

101990

Research center of therapy and prophylactic medicine, Moscow

119192

Moscow State University n.a. M.V. Lomonosov, Moscow

169608

Singapore General Hospital, Singapore

169609

National Heart Centre Singapore, Singapore

198205

City hospital #15, Saint Petersburg

199106

City Pokrovskaya Hospital, Saint Petersburg

443070

Samara Regional Clinical Cardiology Dispensary n.a. Polyakov, Samara

650002

Sci-Res. Institute of Complex Cardiovascular Disorders, Kemerovo

1311001

Health Corporation of the Ziv Medical Center (R.A.), Safed

1528001

The Baruch Padeh Medical Center, Poria, Tiberias

1834111

HaEmek Medical Center, Afula

3109601

Rambam Health Corporation, Haifa

3810101

Hillel Yaffe Medical Center, Hadera

5262000

Chaim Sheba Medical Center, Ramat Gan

7030000

Shamir Medical Center (Assaf Harofeh), Zrifin

7610001

Kaplan Medical Center, Rehovot

9112001

Hadassah Hebrew University Hospital Ein Kerem, Jerusalem

06611

Cardiology Associates of Fairfield County, PC, Trumbull

78212-4740

Clinical Advancement Center, PLLC, San Antonio

B1740ETD

Clínica DIM, Ramos Mejía

B2900DMH

Instituto de Investigaciones Clínicas San Nicolás, San Nicolás de los Arroyos

C1425DES

Centro de Investigaciones Clínicas, Buenos Aires

C1426EGR

Centro de Medicina Integral e Investigacion Clínica, CABA

C1440CFD

Centro de Especialidades Médicas, Villa Luro

S2000DSV

Sanatorio Parque S.A., Rosario

S3000FWO

Centro de Investigaciones Clinicas del Litoral, Santa Fe

T6G 2B7

University of Alberta, Edmonton

V3V 0C6

SMH Cardiology Clinical Trials Inc, Surrey

P3E 5M4

Cardiovascular CRO Ltd., Greater Sudbury

N6A 5A5

London Health Sciences Centre, London

L3Y 2P6

PACE Cardiology Clinic, Newmarket

L6K 3W7

Oakville Cardiologists, Inc., Oakville

M5B 1W8

St. Michael's Hospital Health Centre, Toronto

H1T 3Y7

Clinique Sante Cardio MC, Montreal

H2X 3H8

Centre De Recherche Du (CRCHUM) - Hotel-Diu, Montreal

J3A 1J2

CardioVasc HR, Inc., Saint-Jean-sur-Richelieu

Unknown

Hospital General de Medellin, Medellín

IPS Centro Cientifico Asistencial S.A.S, Barranquilla

Mediservis del Tolima IPS S.A.S, Ibagué

Fundación Cardiovascular de Colombia, Floridablanca

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz, Budapest

Clinical Trial Systems, Pretoria

04910

Zentrum für Klinische Studien Südbrandenburg GmbH, Elsterwerda

01069

Klinische Forschung Dresden GmbH, Dresden

142 33

Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA, Nea Ionia / Athens

00040

Asl Roma 6, Rome

07100

A.O.U. di Sassari, Sassari

271-0077

Seikeikai New Tokyo Heart Clinic, Matsudo

805-8508

Steel Memorial Yawata Hospital, Kitakyushu

003-0026

Matsuda Cardiovascular clinic, Sapporo

654-0155

National Hospital Organization Kobe Medical Center, Kobe

665-0873

Higashi Takarazuka Satoh Hospital, Takarazuka

920-8650

National Hospital Organization Kanazawa Medical Center, Kanazawa

020-0066

Iwate Prefectural Central Hospital, Morioka

611-0041

Uji-Tokushukai Medical Center, Uji

573-0153

Hirakata kohsai Hospital, Hirakata

596-0042

Kishiwada Tokushukai Hospital, Kishiwada

569-1096

Takatsuki Red Cross Hospital, Takatsuki

569-8686

Osaka Medical College Hospital, Takatsuki

697-8511

National Hospital Organization Hamada Medical Center, Hamada

192-0918

Minamino Cardiovascular Hospital, Hachiōji

143-8541

Toho University Omori Medical Center, Ōta-ku

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

740-8510

National Hospital Organization Iwakuni Clinical Center, Iwakuni

910-8526

Fukui Prefectural Hospital, Fukui

702-8055

Okayama Rosai Hospital, Okayama

558-8558

Osaka General Medical Center, Osaka

930-8550

Toyama Prefectural Central Hospital, Toyama

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

85-681

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ, Bydgoszcz

40-156

CLINICAL MEDICAL RESEARCH Sp. z o. o., Katowice

92-213

SPZOZ Centralny Szpital Kliniczny UM w Lodzi, Lodz

61-848

Szpital Kliniczny Przemienienia Panskiego, Poznan

70-240

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

02-097

Uniwersyteckie Centrum Kliniczne Warszawskiego UM, Warsaw

50-981

IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ, Wroclaw

54-049

Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej, Wroclaw

2755-009

Hospital de Cascais, Alcabideche

4564-007

CHTS - Hospital Padre Americo, Guilhufe

2900-446

CHS - Hospital Sao Bernardo, Setúbal

2801-951

Hospital Garcia de Orta, Almada

1449-005

CHLO - Hospital Sao Francisco Xavier, Lisbon

1500-650

Hospital da Luz - Lisboa, Lisbon

4099-001

CHUP - Hospital Santo Antonio, Porto

08907

Ciutat Sanitària i Universitària de Bellvitge, L'Hospitalet de Llobregat

08940

Hospital Sant Joan Despi Moises Broggi, Sant Joan Despí

08003

Hospital del Mar, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Canadian VIGOUR Centre

OTHER

collaborator

Duke Clinical Research Institute

OTHER

lead

Bayer

INDUSTRY

NCT03547583 - Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF | Biotech Hunter | Biotech Hunter